FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectabl… (NCT03678428) | Clinical Trial Compass
TerminatedPhase 3
FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM
Stopped: Production halt of FUDR in China
China92 participantsStarted 2021-12-31
Plain-language summary
The aim of the trial is to compare the objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases. The patients will be treated with systemic FOLFOXIRI chemotherapy or FUDR/Oxaliplatin hepatic arterial infusion with CPT-11 systemic chemotherapy.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 and ≤70.
* Diagnosed as colorectal adenocarcinoma by histology.
* Confirmed as liver metastases by medical imaging or pathology.
* MDT determined as unresectable liver metastases, defined as:①more than 5 metastases; ②unable to conduct R0 resection; ③no sufficient residual liver volume after resection; ④none of 3 hepatic vein can be reserved after resection, no sufficient blood supply or bibliary duct can be reserved, none of 2 adjacent liver segment can be reserved. Whenever meets any of the criteria mentioned above would be defined as unresectable liver metastases.
* No previous treatment aiming at treating liver metastases, including chemotherapy, surgery, radiotherapy, transcatheter hepatic arterial chemoembolization(TACE) or target therapy.
* Confirmed by CT, MRI or PET/CT(if necessary) that there is no extrahepatic metastases or only oligos extrahepatic metastases(no more than 2 organs and 5 leisions, maximum diameters of single leision ≤ 1cm).
* Unsuitable for cetuximab treatment(RAS mutation, unable to afford the cost).
* No hematologic dysfunction(Platelets \>90Ă—10\^9/L; WBC \>3Ă—10\^9/L; Neutrophil \>1.5Ă—109/L).
* Serum bilirubin ≤ 1.5 × ULN; aminotransferase ≤ 5 × ULN.
* No ascites; no coagulation dysfunction; albumin ≥ 30g/L.
* Hepatic function was classified as class A by Child-Pugh classification.
* Serum creatinine \< 1 Ă— ULN, or creatinine clearance rate(CCR) \> 50ml/min(calculated by Cockcroft-Gault formula).
* ECOG scored as 0-1…
What they're measuring
1
Overall Response Rate and bilateral 95% confidence interval